Prevention of Delayed CINV After Autologous Transplant: Olanzapine-Containing Regimen vs. Dexamethasone-Containing Regimen

NCT07413809 | Recruiting Phase 3 DMC

• 1 other identifier: 2025-097
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This study employs a prospective, multicenter, randomized, two-arm design aimed at evaluating the efficacy and safety of the FTO regimen in preventing delayed chemotherapy-induced nausea and vomiting (CINV) following high-dose chemotherapy for hematopoietic stem cell transplantation (HSCT). A total of 92 patients with multiple myeloma who were indicated for autologous HSCT were enrolled. The primary endpoint was to compare the complete response (CR) rates of the FTO regimen versus the FTD regimen in the delayed phase (24-240 hours after chemotherapy) for preventing nausea and vomiting induced by high-dose chemotherapy during HSCT.

Conditions

Multiple Myeloma

Keywords

Delayed vomiting; Multiple Myeloma; Fosaprepitant; Olanzapine; Tropisetron

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR)

  No vomiting, with or without mild to moderate nausea (scoring 0-7 on the MASCC Antiemesis Tool), and no rescue medication use.

  24 to 240 hours after chemotherapy

Secondary Outcomes (5)

• Major Response (MR)

  0-240 hours after chemotherapy

• Clinical Benefit Response (CBR)

  0-240 hours after chemotherapy

• Minor Response (MiR)

  0-240 hours after chemotherapy

• Treatment Failure (TF)

  0-240 hours after chemotherapy

• Toxic Side Effects

  0-240 hours after chemotherapy

Study Arms (2)

FTO regimen

EXPERIMENTAL

Fosaprepitant, Tropisetron and Olanzapine.

Drug: Fosaprepitant; Drug: Tropisetron; Drug: Olanzapine

FTD regimen

ACTIVE COMPARATOR

Fosaprepitant, Tropisetron and Dexamethasone.

Drug: Fosaprepitant; Drug: Tropisetron; Drug: Dexamethasone

Interventions

Fosaprepitant DRUG

150mg, intravenously every 72 hours from the initiation of preconditioning chemotherapy until day +6 after HSCT

FTO regimen

Tropisetron DRUG

5mg, intravenously 30 minutes before preconditioning chemotherapy on days -3 to -2

FTD regimen; FTO regimen

Olanzapine DRUG

5mg, orally once daily at bedtime until day +8 after HSCT, or until the occurrence of an adverse drug event requiring study termination or death, whichever occurs first

FTO regimen

Dexamethasone DRUG

6mg, orally 30 minutes before chemotherapy on day -3; 3.75mg, orally on days -2 to 0

FTD regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with multiple myeloma who are indicated for autologous hematopoietic stem cell transplantation;
• Preconditioning regimen consists of melphalan at a dose of 200 mg/m²;
• ECOG performance status score of 0 to 2;
• Age \>18 years and \<65 years;
• Expected survival time \>3 months;
• Absence of intracranial hypertension, gastrointestinal obstruction, or other causes of refractory vomiting;
• Ability to understand and provide written informed consent.

You may not qualify if:

• Presence of nausea or vomiting within 48 hours prior to enrollment, with prior use of antiemetic medications;
• Current use or use within the past month of CYP3A4 inducers, inhibitors, or substrate drugs;
• History of hypersensitivity to fosaprepitant or olanzapine;
• Serum creatinine clearance \<60 mL/min;
• Inability to receive treatment and follow-up at the designated study site, or inability to comprehend, comply with the study protocol, or provide informed consent.

Sponsors & Collaborators

• Taizhou Hospital: collaborator
• The Affiliated People's Hospital of Ningbo University: lead
• Zhejiang University: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• The Central Hospital of Lishui City: collaborator
• Jinhua Central Hospital: collaborator
• Shaoxing People's Hospital: collaborator
• Shaoxing Second Hospital: collaborator
• Jinhua People's Hospital: collaborator
• Zhejiang Provincial Tongde Hospital: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Dongyang People's Hospital: collaborator

Study Sites (1)

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

fosaprepitant; Tropisetron; Olanzapine; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Peipei Ye

  The Affiliated People's Hospital of Ningbo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peipei Ye

CONTACT

86-13685832706; 39612903@qq.com

Ying Lu

CONTACT

86-13486090834; 814871416@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: February 17, 2026
• Study Start: October 31, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)